MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR

Model Number 865071

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the spo2 numbers not correct and reliabel from the device.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

After further investigation this complaint is deemed no longer a reportable event.It was reported the device presented with the following: spo2 numbers not correct and reliable.The customer stated that the spo2 numbers not correct and reliable.The philips field service engineer was at the customer site for onsite service.Objective evidence was provided that demonstrates no malfunction occurred, then under such a case the device is operating as designed and as configured.It was confirmed that the reported issue was caused by an non-philips spo2 sensor.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: AVALON FM50 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17245762
• MDR Text Key: 318267422
• Report Number: 9610816-2023-00325
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1